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Neoplasia screening compositions and methods of use

a composition and composition technology, applied in the field of neoplasia screening compositions and methods of use, can solve the problems of invasive procedures that lack sensitivity and accuracy, neoplasia is a significant cause of human morbidity and mortality, and neoplasias, including bladder, renal and prostate cancer, can achieve the effects of improving the sensitivity and accuracy of patient diagnosis, and improving the sensitivity and accuracy o

Active Publication Date: 2013-12-31
THE JOHN HOPKINS UNIV SCHOOL OF MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent describes a method for predicting the response to therapy for cancer patients by measuring the level of methylation at certain promoters in the patient's DNA. These promoters include p16, ARF, GSTP1, MGMT, RAR-β2, TIMP3, CDH1, RASSF1A, LOXL1, LOXL4, and APC. Combining the methylation levels of these promoters can provide a more accurate prediction of tumor stage and response to therapy. The method may be performed using tissue samples or biological samples such as serum or stool.

Problems solved by technology

Neoplasias, including bladder, renal, and prostate cancers, are a significant cause of human morbidity and mortality.
When and if clinical symptoms do develop, patient diagnosis typically involves invasive procedures that lack sensitivity and accuracy.

Method used

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  • Neoplasia screening compositions and methods of use
  • Neoplasia screening compositions and methods of use
  • Neoplasia screening compositions and methods of use

Examples

Experimental program
Comparison scheme
Effect test

example 1

Bladder Cancer Statistical Analysis

[0219]The major statistical endpoint in this study was the quantitative methylation levels for each gene in cancer cases and in controls. From these levels, receiver operating characteristic (ROC) curves were constructed for each of nine genes for the detection of bladder cancer. The value of using a binary cutoff (zero methylation) versus the quantitative level was also explored, via multivariate logistic models. Since four of the genes showed 100% specificity, a two step decision rule was constructed. In the first step, four genes with 100% specificity were used to identify an initial group of cancers. Among the patients in whom none of these genes were methylated, a logistic regression (Cox, D. R. The Analysis of Binary Data. London: Methuen, 1970) utilizing the remaining genes was performed. ROC curves were produced by combining sensitivity and 100% specificity achieved from the first step with the logistic regression results from the second st...

example 2

Renal Carcinoma Statistical Analysis

[0224]All of the statistical tests were performed using Excel software (Microsoft, Redmond, Wash.). The sensitivity of QMSP-based detection of hypermethylation in urine and serum was calculated as number of positive tests / number of cancer cases. The specificity was calculated as number of negative tests / number of cases without genitourinary cancer for urine (and absence of any cancer for serum).

Example 3

Prostate Carcinoma Patients and Sample Collection

[0225]Fifty six patients undergoing prostatectomy for prostate adenocarcinoma and 16 patients undergoing cystoprostatectomy for bladder carcinoma at the Johns Hopkins Hospital between November 2001 and May 2002 (Harden et al., J Natl Cancer Inst, 95: 1634-7, 2003) were included in this study. Immediately after resection, sextant biopsies (apex, mid, and base from right and left sides) were taken from all 72 of the resected prostates and kept frozen at −80° C. The biopsies were sectioned to extract DN...

example 3

Prostate Carcinoma Statistical Analysis

[0228]The medians and ranges of the methylation ratios for the samples was determined. Associations between these values were tested by using the Mann-Whitney U test, and P values<0.05 were considered to be significant.

Example 4

Prostate Sample Collection and DNA Preparation

[0229]Urine samples of fifty-two patients with prostate cancer who underwent curative surgery at the Johns Hopkins University School of Medicine were evaluated. Detailed data on these patients are listed in Table 11. Urine samples from ninety-one age-matched individuals (median age, 56.5 years; range, 28 to 84 years) without a history of genitourinary malignancy were used as controls. Of these ninety-one individuals, nine were diagnosed with benign prostate hyperplasia, ten harbored atypical cells by urine cytology examination, five had primary cancers in other sites (non-small-cell carcinoma of lung, n=1; basal cell carcinoma of skin, n=1; malignant melanoma of leg, n=1; Kap...

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Abstract

As described in more detail below, the present invention generally features compositions and non-invasive methods useful for the screening, identification, monitoring, or diagnosis of subjects having a neoplasia. The invention further provides highly accurate non-invasive methods for the staging or selection of treatment for a bladder, renal, or prostate cancer in a subject.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]This application claims the benefit of the following U.S. Provisional Application Nos. 60 / 652,594, which was filed on Feb. 14, 2005; 60 / 653,295, which was filed on Feb. 16, 2005; 60 / 652,591, which was filed on Feb. 14, 2005; and 60 / 652,590, which was filed on Feb. 14, 2005; each of which is hereby incorporated by reference in their entirety.BACKGROUND OF THE INVENTION[0002]Neoplasias, including bladder, renal, and prostate cancers, are a significant cause of human morbidity and mortality. Bladder cancer is the fourth most common cancer in men and the eighth in women both in terms of incidence and mortality; renal cancer kills approximately 12,000 Americans every year, and 30,000 new cases of renal cancer are reported each year in the United States; and prostate cancer is clinically diagnosed in one of every 11 American men. One third of men diagnosed will prostate cancer will develop a life threatening disease In their earliest stages, bla...

Claims

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Application Information

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Patent Type & Authority Patents(United States)
IPC IPC(8): A61K49/00C12Q1/68
CPCC12Q2600/154C12Q2600/106C12Q2600/112C12Q1/6886C12Q1/6827C12Q2537/164C12Q2537/143C12Q2525/143C12Q2565/501
Inventor SIDRANSKY, DAVID
Owner THE JOHN HOPKINS UNIV SCHOOL OF MEDICINE
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